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Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

NCT05256290 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-12-09

No results posted yet for this study

Summary

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of silevertinib (BDTX-1535). The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles.

Phase 1 enrollment is now complete. Phase 2 is currently ongoing.

Conditions

  • Non-Small Cell Lung Cancer
  • Advanced Non-Small Cell Squamous Lung Cancer
  • Metastatic Lung Non-Small Cell Carcinoma
  • Metastatic Lung Cancer
  • NSCLC
  • Advanced Lung Carcinoma
  • Epidermal Growth Factor Receptor C797S
  • Epidermal Growth Factor Receptor G719X
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR-TKI Resistant Mutation

Interventions

DRUG

silevertinib (BDTX-1535) monotherapy

Silevertinib (BDTX-1535) is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC.

Sponsors & Collaborators

  • Black Diamond Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Black Diamond Therapeutics · Black Diamond Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2025-11-03
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256290 on ClinicalTrials.gov